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NDC 53329-0688-30 Naproxen Sodium 220mg 220 mg/1 Details

Naproxen Sodium 220mg 220 mg/1

Naproxen Sodium 220mg is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Medline Industries, LP. The primary component is NAPROXEN SODIUM.

MedlinePlus Drug Summary

Prescription naproxen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), juvenile arthritis (a form of joint disease in children), and ankylosing spondylitis (arthritis that mainly affects the spine). Prescription naproxen tablets, extended-release tablets, and suspension are also used to relieve shoulder pain caused by bursitis (inflammation of a fluid-filled sac in the shoulder joint), tendinitis (inflammation of the tissue that connects muscle to bone), gouty arthritis (attacks of joint pain caused by a build-up of certain substances in the joints), and pain from other causes, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription naproxen is used to reduce fever and to relieve mild pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Naproxen is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.

Related Packages: 53329-0688-30
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Naproxen

Product Information

NDC	53329-0688
Product ID	53329-688_e9d34869-ede4-2a14-e053-2995a90a61fd
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Naproxen Sodium 220mg
Proprietary Name Suffix	n/a
Non-Proprietary Name	Naproxen Sodium
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	220
Active Ingredient Units	mg/1
Substance Name	NAPROXEN SODIUM
Labeler Name	Medline Industries, LP
Pharmaceutical Class	Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA090545
Listing Certified Through	2024-12-31

Package

Package Images

NDC 53329-0688-30 (53329068830)

Pricing Information	N/A
NDC Package Code	53329-688-30
Billing NDC	53329068830
Package	100 TABLET in 1 BOTTLE (53329-688-30)
Marketing Start Date	2018-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6d9b3581-63b5-699e-e053-2991aa0a68f8 Details

Active ingredient (in each tablet)

Naproxen sodium, USP 220 mg

(naproxen 200 mg) (NSAID*)

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/ fever reducer

Uses

temporarily relieves minor aches and pains due to:
headache
muscular aches
minor pain of arthritis
toothache
backache
the common cold
menstrual cramps
temporarily reduces fever

Warnings

Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

hives
facial swelling
asthma (wheezing)
shock
skin reddening
rash
blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
have 3 or more alcoholic drinks every day while using this product
take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
take more or for a longer time than directed.

Do not use

if you have ever had an allergic reaction to any other pain reliever/fever reducer
right before or after heart surgery

Ask a doctor before use if

stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
you are taking a diuretic
you have problems or serious side effects from taking pain relievers or fever reducers
you have asthma

Ask a doctor or pharmacist before use if you are

under a doctor's care for any serious condition
taking any other drug

When using this product

take with food or milk if stomach upset occurs
the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding

feel faint
vomit blood
have bloody or black stools
have stomach pain that does not get better
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
you have difficulty swallowing
it feels like the pill is stuck in your throat
redness or swelling is present in the painful area
any new symptoms appear

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

do not take more than directed
the smallest effective dose should be used
drink a full glass of water with each dose
adults and children 12 years and older:
take 1 tablet every 8 to 12 hours while symptoms last
for the first dose you may take 2 tablets within the first hour
do not exceed 2 tablets in any 8- to 12-hour period
do not exceed 3 tablets in a 24-hour period
children under 12 years: ask a doctor

Other information

each tablet contains: sodium 20 mg
store at 20° to 25°C (68° to 77°F). Avoid high humidity and excessive heat above 40°C (104°F).

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, FD&C blue # 2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

Manufacturing Information

Manufactured by:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in India

www.medline.com

1-800-MEDLINE (633-5463)

REF: OTCM00012

V2 RH22HND

Package Label

INGREDIENTS AND APPEARANCE

NAPROXEN SODIUM 220MG

naproxen sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-688
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)	NAPROXEN SODIUM	220 mg

Ingredient Name	Strength
Inactive Ingredients
POVIDONE K90 (UNII: RDH86HJV5Z)
WATER (UNII: 059QF0KO0R)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	blue	Score	score with uneven pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	141
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-688-30	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090545	08/01/2018

Labeler - Medline Industries, LP (025460908)

Revised: 8/2022

Document Id: e9d34869-ede4-2a14-e053-2995a90a61fd

Set id: 6d9b3581-63b5-699e-e053-2991aa0a68f8

Version: 6

Effective Time: 20220831